Wearable technologies in respiratory functional assessment - Andrea Aliverti Dipartimento di Elettronica, Informazione e Bioingegneria

Wearable technologies in respiratory functional
                assessment
                         Andrea Aliverti

       Dipartimento di Elettronica, Informazione e Bioingegneria
                      Politecnico di Milano, Italy
                         andrea.aliverti@polimi.it

Conflict of interest disclosure
 I have no real or perceived conflicts of interest that relate to this presentation.

 I have the following real or perceived conflicts of interest that relate to this presentation:

Affiliation / Financial interest                           Commercial Company
Grants/research support:

Honoraria or consultation fees:
LIFE Italia
Participation in a company sponsored bureau:

Stock shareholder:

Spouse / partner:

Other support / potential conflict of interest:

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OUTLINE

• What does it mean “wearable devices”?

• What does it mean “wearable biomedical devices”?

• What is a digital health ecosystem?

• What and how to measure for to assess respiratory function?

• What’s for?

QUESTION 1
              WHICH OF THE FOLLOWING
        DO YOU CONSIDER A WEARABLE DEVICE?
   A handheld spirometer
   A wellness/lifestyle app for the smartphone
   A smartwatch
   A pulse oximeter
   A glucometer
   A smart weight scale

TODAY THERE IS AN OVERWHELMING NUMBER OF
       TRENDING WEARABLE DEVICES

   Technological complexity

                              Width of functionalities

WEARABLE DEVICES
• “Wearable” means whatever a subject can wear, as
  sweaters, hats, pants, eyeglasses, bras, socks, watches,
  patches or devices just fixed on the belt, without
  encumbering daily activities or restricting the mobility.

• The concept of wearability is of particular importance in
  fields like monitoring for healthcare, wellbeing and
  fitness/sport.

• Very often wearable technology is based on
  conventional electronics, either rigid or bendable,
  powered by conventional batteries. This includes mobile
  phone peripherals or similar, i.e. devices, interfaces or
  sensors connected to the phone.

• In other cases, wearable technology is more ‘disruptive’
  and includes apparel and textiles with distributed
  functions, in which electronics is intimately combined. In
  this case, the development is not obvious because
  devices have to be washable, stretchable, foldable,
  sometime printable or transparent.

TECHNOLOGICAL TREND

          Handheld/        wearable              wearable           attachable
  lab                                                                             implantable    ingestible
          portable          devices               devices             devices
devices                                                                             Devices       devices
           devices    (rigid electronics)   (flexible, e-textile)   (e-tattoos)
                                                                                  (under skin)

Aliverti et al, 2017

MEDICAL DEVICE

Any instrument, apparatus, appliance, software, material or other article, whether used alone or
in combination, including the software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of: diagnosis, prevention,
monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap; investigation, replacement or modification of the
anatomy or of a physiological process; control of conception; and which does not achieve its
principal intended action in or on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function by such means.

The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking
account of the potential risks associated with the devices. The classification rules are based on different criteria such as
the duration of contact with the patient, the degree of invasiveness and the part of the body affected by the use of
the device.

From: www.medtecheurope.org

The medical device (MD) sector is regulated by Directives 93/42/EC and 90/385/EEC.
From 2021, the new Regulation 2017/745/EU will fully apply in Europe.

Classification of medical devices (estimated to be more than 500.000) drives many
pre- and postmarket requirements.

Due to the large variety of products, the level of control made by a thirdparty (the
“notified body”) before placing them in the market depends on the level of impact on
the human body that their use might imply.

The same notified body is involved post-market to ensure the continued safety and
performance of medical devices.

Under the MD Directive, MDs are classified into 4 classes following a risk based
classification system.

BODY AREA NETWORKS (BAN)
                     (OR BODY SENSOR NETWORKS, BSN)

          Environmental
             sensors                          Sensors of
                                              physiological
                                              parameters

            Activity/motion
                                               IoT devices

                                             Body area
                                           network (BAN)

Aliverti, Breathe, 2017

Sim, N Engl J Med, 2019

 In BANs systems the communication
is entirely within, on, or in the immediate
proximity of a human body.

TELEMONITORING SYSTEM:
                            TWO-HOP DATA TRANSMISSION ARCHITECTURE

Angelucci and Aliverti, Pulmonology, 2020

DIGITAL HEALTHCARE ECOSYSTEM

• infrastructure that supports the shift from an organization-centric to a
  patient-centric model of delivering healthcare services using digital
  platforms to encourage cross-organizational, multidisciplinary, and
  collaborative healthcare delivery.

• the infrastructure comprises an internet platform that offers digital
  healthcare services. It promotes interoperability by allowing
  intercommunication among healthcare professionals. It also enables the
  sharing of Electronic Health Records (EHR)

Sim, N Engl J Med, 2019

QUESTION 2
            WHICH ARE THE THREE CHARACTERISTICS
       OF M-HEALTH THAT YOU CONSIDER MOST IMPORTANT?

 Privacy                        Effectiveness
 Transparency                   Accessibility
 Reliability                    Scalability
 Clinical validity              Safety
 Interoperability               Security
 Technical stability

Ding, IEEE Reviews in Biomedical Engineering, 2020

A HOME TELEMEDICINE SYSTEM FOR CONTINUOUS
                    RESPIRATORY MONITORING
Angelucci, Kuller, Aliverti; IEEE Journal of Biomed and Health Informatics, 2021

Angelucci, Kuller, Aliverti; IEEE Journal of Biomed and Health Informatics, 2021

QUESTION 3
  WHICH ARE THE THREE PARAMETERS THAT YOU CONSIDER THE MOST
IMPORTANT FOR CONTINUOUS MONITORING OF RESPIRATORY FUNCTION
                        BY WEARABLES?

   Forced Vital capacity          Dyspnea
   Tidal volume                   Posture
   Oxygen saturation              Blood pressure
   Peak Expiratory Flow           Oxygen consumption
   Motion                         Body temperature
   Heart rate                     Lung sounds
   Respiratory rate               Number of coughs

HEART RATE /
CARDIAC FUNCTION

PATCHES
          VitalPatch (VitalConnect, USA)

•   ECG watch band (KardiaBand, AliveCor,
                                                  USA), connected to an AppleWatch for the
                                                  detection of atrial fibrillation (AF)
                                              •   introduced in Nov 2017 as the first FDA-
                                                  approved AppleWatch accessory for the
                                                  diagnosis of AF
                                              •   the device records a 30-s segment of
                                                  single- lead ECG data when the user
                                                  places his or her finger on the electrode
                                                  embedded in the smartwatch band
                                              •   data are then transmitted via Bluetooth to a
                                                  smartphone application.
Nat Rev Cardiol. 2018 Nov; 15(11): 657–658.

•   419,297 participants enrolled
•   0.52% received an irregular pulse notification
•   among those with an initial notification who returned an ECG patch, 84%
    (95% CI, 76 to 92) of their subsequent notifications were confirmed to be
    atrial fibrillation.
•   “…These estimates may help providers better understand the implications
    of irregular pulse notifications when patients present for clinical care…”

PHYSICAL ACTIVITY

PULMONARY FUNCTION /
  RESPIRATORY RATE

RESPIRATION (RATE) MONITORING METHODS

•   Contact-based methods
    –   respiratory airflow
    –   respiratory related chest or abdominal movements
    –   respiratory sounds
    –   respiratory CO2 emission
    –   oximetry probe SpO2
    –   respiration rate derived from the electrocardiogram (EDR)

•   Noncontact-based methods
    – Radar Based Respiration (Rate) Monitoring
    – Optical Based Respiration (Rate) Monitoring
    – Thermal Sensor and Thermal Imaging Based Respiration (Rate) Monitoring

SYSTEM FOR RESPIRATORY MONITORING THROUGHOUT THE
               DETECTION OF CHEST-WALL SURFACE DISPLACEMENTS

• distances (‘diameters’)

• perimeters
  (‘circumferences’)

• cross sectional areas
                            Structured light
• surfaces                  Plethysmography (SLP)

                                 Opto-Electronic
• volumes                    Plethysmography (OEP)

SYSTEM FOR RESPIRATORY MONITORING THROUGHOUT THE
              DETECTION OF CHEST-WALL SURFACE DISPLACEMENTS

• distances (‘diameters’)                     RespirHo, Politecnico di Milano

SYSTEM FOR RESPIRATORY MONITORING THROUGHOUT THE
              DETECTION OF CHEST-WALL SURFACE DISPLACEMENTS

• distances (‘diameters’)

• perimeters
  (‘circumferences’)

Different postures
      at rest

                      standing seated supine right side left side   standing seated supine right side left side

Different levels of
     exercise

ECG x 4 electrodes (2 Leads)
                                                                                                 ECG
Circumferential Respiration                                                                      Heart rate variability
Sensors x3
. Thorax                                                                                         Respiratory rate
. Xiphoid                                                                                        Respiratory variability
. Abdomen                                                                                        Tidal volume
Temperature
                                                                                                 Skin temperature
Pulse Oximeter on chest to
                                                                                                 SpO2
free hands

Accelerometer x1*                                                                                Movement / posture
Gyroscope x1*
Magnetometer x1*
*1 IMU (Logger)

                                                    4G or 5G Phone Module
                                Processor 1.8GHz 64-bit quad-core ARM Cortex-A53 CPU 4GB RAM
                               Storage 64 Gb USB 3.0 (type C) On board WiFi 11a/b/g/n/ac 2.4/5
                               GHz On board Bluetooth Low Energy 5.0 Modem 4G eSIM compatible
                                    Battery 3600 mA/h GPS Ergonomic and soft touch Easy Plug

https://www.x10x.com/

• distances (‘diameters’)

• perimeters
  (‘circumferences’)

• cross sectional areas

VALIDATION OF THE HEXOSKIN WEARABLE VEST DURING
                 LYING, SITTING, STANDING, AND WALKING ACTIVITIES

Appl. Physiol. Nutr. Metab. 40: 1–6 (2015)

COMMERCIALLY AVAILABLE WEARABLE PULSE OXIMETERS

Ding et al, IEEE Reviews in Biomedical Engineering, 2020

QUESTION 4
      INDICATE THE THREE DISEASES AND/OR FIELDS
    IN WHICH YOU THINK WEARABLES CAN BE USEFUL

   COPD                     Pediatrics
   Asthma                   Rehabilitation
   Covid-19                 Sleep and breathing
   OSAS                      disorders
   Cystic fibrosis          Critical care
   Lung cancer              Interstitial lung disease

COVID-19 STUDIES

(Zhu, Discrete Dyn Nat Soc, 2020)
• heart rate, activity, and sleep data collected from Huami wearable devices + anomaly detection
   algorithm
• identification of outbreaks of COVID-19. At a population level an correlation with the measured
   infection rate.

(Menni, Nat Med, 2020)
• symptoms reported through a smartphone app + model
• prediction of the likelihood of COVID-19

(Marinsek, preprint on medrxiv)
• data from Fitbit devices
• early detection and management of COVID-19.

(Miller, preprint on medrxiv)
• respiration rate from Whoop devices
• detection of COVID-19

data on 2745 subjects diagnosed with COVID-19 using the active infection PCR swab test with test dates
           ranging from February 16 to September 9, 2020. All subjects wore Fitbit devices

•   Physiological and activity data from 32 individuals infected with COVID-19, identified from a cohort of
    nearly 5,300 participants

•   26 of them (81%) had alterations in their heart rate, number of daily steps or time asleep.

•   Of the 25 cases of COVID-19 with detected physiological alterations for which symptom information
    was available, 22 were detected before (or at) symptom onset, with four cases detected at least nine
    days earlier.

Mishra et al, Nat Biomed Eng, 2020

Mishra et al, Nat Biomed Eng, 2020

COPD EXACERBATION

COPD EXACERBATION

Yanez et al, Chest, 2012

• 16 studies showing positive results in predicting/detecting an exacerbation
  episode via monitoring of physiological parameters.

• approach appears to be promising, however, further well-designed clinical
  trials are required to investigate the true magnitude and time-course pre,
  during, and post an exacerbation episode of changes in physiological
  parameters

Angelucci and Aliverti, Pulmonology, 2020

Respiratory rate (breaths/min)
Nicolo’ et al, Sensors, 2020

QI W, ALIVERTI A.
A MULTI-MODALITY WEARABLE SYSTEM FOR CONTINUOUS AND REAL-
 TIME BREATHING PATTERNS MONITORING DURING DAILY ACTIVITIES
     IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS

Qi and Aliverti, IEEE J Biomed and Health Informatics, 2020

Qi and Aliverti, IEEE J Biomed and Health Informatics, 2020

Future perspectives (1/2)

• Mobile health technologies are evolving from descriptive monitoring
  tools to digital diagnostics and therapeutics that synergize tracking
  with behavioral and other interventions to directly affect health
  outcomes

• Major challenges
    – discovery and validation of meaningful digital biomarkers
    – regulation of and payment for mobile health technologies
    – integration into frontline care

Future perspectives (2/2)

• Still to be defined how mobile health technology can concretely
  affect clinical outcomes, along with more rigorous evaluations of
  clinical effectiveness.

• Concerns and risks can be reduced through
    – Improved digital literacy among patients
    – Ethical codes of conduct for developers and regulators of m-health
    – transparency and accountability in how health care organizations adopt m-
      health